Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 14 for:    GSDIa

Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708015
Recruitment Status : Completed
First Posted : January 13, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Ultragenyx Pharmaceutical Inc

Tracking Information
First Submitted Date January 11, 2021
First Posted Date January 13, 2021
Last Update Posted Date May 10, 2022
Actual Study Start Date November 5, 2020
Actual Primary Completion Date March 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2021)
Percentage of time spent in normal glucose control (defined as glucose levels between 70 mg/dL - 120 mg/dL) over a seven-day period [ Time Frame: 7 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2021)
  • Total number of low glycemic events (< 70 mg/dL) over a seven-day period [ Time Frame: 7 days ]
  • Percentage of time where low glucose values were (< 70mg/dL) over a seven-day period [ Time Frame: 7 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa
Official Title A Retrospective Observational Clinical Study on the Use of Continuous Glucose Monitoring for Glycemic Control in Adult and Pediatric Patients With Glycogen Storage Disease Type Ia (GSDIa)
Brief Summary The primary objective of this study is to assess the percentage of time patients were in normal glucose control.
Detailed Description Retrospective Dexcom G6 iCGM data stored in the Clarity cloud from eligible patients will be accessed and downloaded, stripped of patient-identifying information and provided to the contract research organization (CRO) to review prior to sending to the Sponsor for analysis of glycemic control. The CRO will ensure data shared with the Sponsor is de-identified and transferred over a secure file transfer platform. Further, Remote Site Specialists (RSSs) from the CRO will work with the healthcare providers (HCPs) from participating sites to obtain additional patient data including medical history, prescribed diet, cornstarch/Glycosade use and demographic data directly, if available, from the medical charts and will enter this information into an electronic data capture (EDC) system.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male and female patients eight years of age and older with GSDIa, who have used the Dexcom G6 iCGM for glycemic control, and with at least one month of CGM data available on the Dexcom Clarity cloud.
Condition Glycogen Storage Disease Type IA
Intervention Other: No Intervention
A retrospective chart review of medical records
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 9, 2022)
16
Original Estimated Enrollment
 (submitted: January 11, 2021)
30
Actual Study Completion Date March 4, 2022
Actual Primary Completion Date March 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of GSDIa confirmed by either liver biopsy or molecular testing.
  • Currently using the Dexcom G6 iCGM for glycemic control and with approximately one (1) month of CGM data available on the Dexcom Clarity cloud and have authorized sharing of data with thereferral center through the Dexcom Clarity app.

Exclusion Criteria:

  • Presence or history of any disease, condition or chronic medication that, in the Investigator's opinion, would significantly affect interpretation of study results.
  • Use of any investigational product or investigational medical device within 30 calendar days preceding screening or before completion of all scheduled study assessments during study enrollment.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04708015
Other Study ID Numbers DTX401-CL001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ultragenyx Pharmaceutical Inc
Study Sponsor Ultragenyx Pharmaceutical Inc
Collaborators Not Provided
Investigators
Study Director: Medical Director Ultragenyx Pharmaceutical Inc
PRS Account Ultragenyx Pharmaceutical Inc
Verification Date May 2022